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Unredacted complaint reveals fentanyl manufacture Teva/Cephalon’s illegal marketing strategies

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~ Newly unsealed information shows for the first time the extent to which Teva/Cephalon lied about the uses and risks of their fentanyl drugs to boost sales ~

RICHMOND (February 10, 2020) – Newly unsealed information shows for the first time the extent to which Teva Pharmaceuticals, USA, Inc. and its predecessor Cephalon Inc. lied about the uses and risks of their fentanyl drugs to boost sales. The scale of Teva and Cephalon’s lies and deception was revealed in a newly unredacted Complaint in Attorney General Mark Herring’s lawsuit against the companies for their role in creating and perpetuating the opioid crisis through their unlawful, decades-long campaign to boost sales and deceive the public about these drugs. The unredacted Complaint shows how the companies took opioids the FDA had only approved for treating cancer patients’ pain and aggressively marketed them for a wide variety of prohibited off-label uses and encouraged non-cancer treating doctors, a third of whom were primary care physicians, to misprescribe these powerful drugs; discloses the FDA’s previously unknown stern warnings about the drugs, which the companies subsequently ignored; and shows how the companies manipulated clinical trial data to hide what they knew about their drugs’ addiction and overdose risks and how they exaggerated the drugs’ overall efficacy and benefits.

“Teva and Cephalon blatantly lied about the usage, the efficacy, and the risks of their extremely dangerous and addictive drugs in order to make billions of dollars in profit,” said Attorney General Herring. “Families in Virginia and around the country have been devastated by the ongoing opioid epidemic, which has its roots in the boardrooms and marketing departments of companies like Teva and Cephalon. This unredacted Complaint reveals how these opioid manufacturers had absolutely no problem with putting human lives at risk in order to make as much money as they could. I will not stop until pharmaceutical companies are held accountable and shoulder the financial burden for their role in creating and prolonging the opioid crisis.”

Since 2007, fatal fentanyl overdoses in Virginia have risen by nearly 1,600%, from just 48 in 2007 to more than 800 in 2018. In the same period, nearly 10,000 Virginians have died of a heroin or opioid overdose, including 5,700 from a prescription overdose, and nearly 3,500 from a fentanyl overdose, all while Teva/Cephalon made huge sums of money from its fentanyl drugs.

In October 2019, Attorney General Herring filed suit against opioid manufacturer Teva/Cephalon for engaging in what he alleges was an unlawful, complex, decades-long campaign to boost sales of fentanyl – the most potent narcotic currently approved for human use – by marketing its rapid acting fentanyl drugs for unapproved and unsafe uses, and by knowingly and intentionally downplaying the risks of its drugs while overselling the benefits.

Unlawfully Marketing and Promoting Cancer Pain Drugs for Non-Cancer Related Conditions
In 2008, Cephalon settled federal criminal charges and state civil charges for illegally marketing Actiq, a potent rapid-release form of fentanyl, which was administered via a raspberry-flavored fentanyl lollipop. Attorney General Herring’s unredacted Complaint reveals the involvement of Cephalon’s top managers in targeting and encouraging doctors to prescribe Actiq for a wide range of unapproved symptoms and issues, including “acute pain, premedication for procedures, post-surgical pain, kidney stones, tooth extractions, migraine pain, back pain, neuropathic pain, headache pain, arthritis, or fibromyalgia.”

The unredacted Complaint shows how these managers participated in conferences at high-end resorts, where they ostensibly “educated” high prescribers of other opioids about the benefits of Actiq for uses forbidden by the FDA using “educational” materials that they never submitted to the FDA. The unredacted Complaint shows how the conferences persuaded providers to go back to their home states, including Virginia, and use Actiq for unsafe and unapproved uses, all while Cephalon was telling the FDA it was discouraging the uses.

One email from a Cephalon agent to Andy Pyfer, Cephalon’s brand manager for Actiq, captures the company’s sales goals efforts at the time, summarizing a well-attended conference at a five-star San Diego resort by saying: “It was a great meeting. I think we definitely sold some Actiq.”

The unredacted Complaint also reveals for the first time the scope of Cephalon’s illegal sales practices at this time. It shows Cephalon aggressively targeted non-cancer prescribers and doctors with sales and promotional visits, including doctors specializing in “primary care, family medicine, physical medicine, and neurology,” even though the drugs were only FDA approved to treat cancer patients. Below is a breakdown of Cephalon’s sales calls in the first seven months of 2004:

The unredacted Complaint also reveals Cephalon’s “ride ‘em up ride ‘em down policy,” which encouraged salespeople to repeatedly target high prescribers up until the point authorities stepped in and stopped the prescriber. As the Complaint explains: “as a high-performing Florida salesperson put it about a high prescribing doctor…‘i[f] I knew that this physician was in town practicing medicine, I would’ve been in there three times a week pushing him to write more Actiq’”. Cephalon even “affirmatively told salespeople not to report or flag doctors who salespeople knew were prescribing Fentora off-label for the wrong conditions”.

Cephalon Ignored FDA Warnings
The unredacted Complaint reveals a previously unknown series of meetings between the FDA and Cephalon in 2004, in which top FDA officials warned Cephalon that the use of Actiq by non-cancer patients was “staggering…the Agency is very concerned that the situation that occurred with Oxycontin may happen again.” The FDA told Cephalon its sales practices were creating a “significant public health” problem, by providing non-cancer patients with a product so powerful it put them at risk of an immediate overdose.

The unredacted Complaint also reveals that Cephalon did not substantially change its practices with the introduction of Actiq’s successor Fentora, in 2006, a rapid-release fentanyl tablet. The company kept targeting providers who were prescribing Fentora for back pain, and other non-cancer conditions, and it kept turning a blind eye to the resulting problems.

Below is an egregious example of a company-approved response to a Q&A produced for their salespeople:

Knowingly Downplaying Risks of Abuse and Overdose While Overselling Benefits and Efficacy
The unredacted Complaint discloses clinical trial data showing that Cephalon and then Teva, which acquired Cephalon in 2011, knew Actiq and Fentora were widely abused and misused by clinical trial patients and knew the drugs were showing potentially alarming diminution in pain relief the longer the patients used them.

The unredacted Complaint reveals that data from clinical trials of Fentora showed that the drug “increased the risk of addiction while bringing fleeting and diminishing relief” and that “patients taking Actiq or Fentora for months or longer exposed themselves to extremely high risks and diminishing pain relief.” According to the unredacted Complaint, in one 18 month clinical trial patients had a:
• 31% increase in pain episodes per day, from 3.5 to 4.6 episodes/day;
• Took 26% more Fentora tablets per day, from 3.5 to 4.4 tablets/day; and
• Had a 42% increase in their average daily Fentora dosage, from 2,162 mcg/day to 3,088 mcg/day.

The companies ghostwrote publications in prominent academic journals, like Cancer, that deliberately misled prescribers and patients about these potential declines in the opioids’ pain relieving properties over time. As the unredacted Complaint notes of the Cancer publication about a long-term study of Fentora use by cancer patients, “the actual study data…suggested the opposite of what Cephalon claimed: that the patients who were in study for 12 months or more actually experienced a decline in analgesic efficacy, suggesting an increase in incremental tolerance to Fentora because they were taking more and more doses per day of Fentora and other opioids.” The unredacted Complaint shows that Teva made efficacy claims a “key pillar” of its marketing campaigns for Fentora from 2008 to the present, all while relying on misleading data.

Additionally, the companies were well aware of, but largely did not disclose, alarming clinical trial data about misuse, abuse, and addiction involving Fentora. The unredacted Complaint details how clinical trial patients in long-term cancer and non-cancer trials, none of whom had a history of substance abuse, started exhibiting alarming drug seeking behaviors, what the companies called “aberrant drug related behavior.”

For example, in one non-cancer long-term clinical trial there were frequent incidents of abuse and misuse:
• 11 patients overdosed;
• One patient’s husband overdosed;
• 35 patients reported their Fentora stolen;
• Dozens of patients dropped out of the trial without accounting for the 100-plus Fentora tablets they had been given; and
• Five study centers reported Fentora stolen from supposedly secured lockers.

The company claimed in limited disclosures to regulators like the FDA and its European Union counterpart, that the rates of aberrant drug related behavior in study patients were around 17%. Both the FDA and the EU thought this was alarming, and Cephalon’s internal discussions showed that medical staff believed this 17% rate could rise to “more than 41%” if patients took Fentora and other opioids for a year or more.

The unredacted Complaint also alleges that in marketing materials and publications disseminated to healthcare providers, academics, and the public, Teva and Cephalon knowingly omitted this data, failing to list these serious cases of misuse and abuse in its tables of adverse events, all while claiming its products were “generally safe” and “well tolerated.”

Attorney General Herring’s Work to Address the Opioid Crisis
As part of his ongoing efforts to hold pharmaceutical companies accountable for their role in creating and prolonging the opioid crisis, Attorney General Herring has also filed suit against Purdue Pharma and members of the Sackler Family, the owners of Purdue, alleging decades of illegal conduct designed to enrich the company and family by selling the most opioids possible. In his suit against the Sackler family, filed in September 2019, Attorney General Herring also alleges that the family fraudulently extracted billions of dollars from the company in an effort to put the money beyond the reach of investigators and those suing the company.

Attorney General Herring also continues to participate in a bipartisan, multistate effort to investigate and hold opioid manufacturers and distributors accountable for their roles in the opioid crisis.

The heroin and prescription opioid epidemic has been a top priority for Attorney General Herring. He and his team continue to attack the problem with a multifaceted approach that includes enforcement, education, prevention, and legislation to encourage reporting of overdoses in progress, expand the availability of naloxone, and expand access to the Prescription Monitoring Program. He has supported federal efforts to improve the availability of treatment and recovery resources and made prescription drug disposal kits available across the Commonwealth.

Download the unredacted complaint here.

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Governor Northam COVID-19 update briefing – March 27, 2020

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Governor Northam joins the Virginia Emergency Support Team to share the latest updates on the COVID-19 response. Here is the latest update:

 

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Virginia U.S. Attorneys issue statement on Virginia recommendations regarding medical prescriptions during COVID-19 pandemic

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On Wednesday, March 25, 2020, Virginia Health Commissioner Dr. Norman Oliver, in response to a surge in demand of potential treatments for COVID-19 for drugs commonly used to treat rheumatoid arthritis, HIV, lupus, malaria, and bacterial infections, reminded physicians and pharmacists that these life-sustaining medications should only be dispensed under specified limited circumstances based on legitimate medical need. Dr. Oliver also warned against improper dispensing and potential hoarding of these medications.

On March 27, 2020, U.S. Attorneys Thomas Cullen and Zach Terwilliger issued a statement confirming that federal prosecutors are aware of Dr. Oliver’s warnings regarding this increased demand and potentially improper behavior by physicians and other health-care providers who may be improperly prescribing these drugs to themselves, their families, and others without a legitimate medical purpose. The U.S. Attorney’s Offices for the Eastern and Western Districts of Virginia, as part of their joint COVID-19 Fraud Task Force, will be closely monitoring this disturbing trend and are prepared to investigate potential violations of federal and state law committed by any individuals or entities, including physicians, dentists, and other healthcare providers, related to these prescription drugs.

“At a time when many doctors, nurses, and first responders are risking their health and personal safety to treat those affected by the coronavirus, it is incredibly disturbing that a selfish minority in that field may be undermining these valiant efforts by prescribing outside legitimate medical practice,” said U.S. Attorney Cullen. “We will work closely with our federal, state, and local partners to identify unscrupulous physicians and other health-care providers who are putting their own well-being ahead of those with a true medical need and hold them accountable under the law.”

“Our office is committed to protecting the public at this critical time, including Virginians who rely on life-sustaining prescription drugs,” said U.S. Attorney Terwilliger. “We will act swiftly in coordination with our law enforcement partners to safeguard these critical medications for those who need them against healthcare providers who improperly dispense them.”

If you believe you have been a victim of fraud, or need more information about COVID-19, please visit: https://www.justice.gov/usao-wdva/covid-19-fraud

For more information from the U.S. Attorney’s Office for the Eastern District of Virginia, please visit: https://www.justice.gov/usao-edva

To report fraud directly to the FBI, please visit their website at https://www.ic3.gov/default.aspx

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Governor Northam encourages Virginians to complete 2020 Census online amid COVID-19 outbreak

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RICHMOND—Governor Ralph Northam today encouraged Virginians to complete the 2020 Census online as the country works to stop the spread of the novel coronavirus or COVID-19. This week, households across Virginia began receiving invitations from the U.S. Census Bureau to complete the 2020 Census. For the first time ever, individuals are able to complete their forms online, via phone, or mail. The statewide virtual Week of Action from Friday, March 27 to Thursday, April 2 will highlight Census Day on April 1, and encourage Virginians to participate in the 2020 Census.

“Though many Virginians are focused on COVID-19, it is still crucial that everyone takes time to complete the 2020 Census, which can be done quickly and easily online,” said Governor Northam. “Counting every person in the Commonwealth will ensure that we receive our portion of the more than $675 billion in federal funding that will be allocated to states for important programs, from Medicaid to school breakfasts.”

By last Friday, an estimated 140 million households had received an invitation from the U.S. Census Bureau to complete the 2020 Census. To date, approximately 18.6 million households have responded to the Census. Though data collection continues, the U.S. Census Bureau has modified some of its field operations during the COVID-19 outbreak.

Today, Governor Northam also announced a Virtual Statewide Week of Action, which includes Census Day on Wednesday, April 1. From Friday, March 27 through Thursday, April 2, Virginians are encouraged to virtually promote the 2020 Census and “Determine Your Decade: YOUR Representation. YOUR Community Funding. YOUR Civic Duty.”

A full list of events is located below:

Friday, March 27 – Sunday, March 29 | Interfaith Engagement
Faith Leaders and communities are encouraged to commit to being a faith partner through the following efforts:

  • Religious Teachings: Incorporate Census messaging into a virtual sermon, lesson, litany, or other teachings. This is an opportunity to preach or teach on the importance of being counted in the 2020 Census.
  • Announcement or Presentation: Allow a member of the U.S. Census Bureau, Office of the Secretary of the Commonwealth, Virginia Complete Count Commission, or a local Complete Count Committee to virtually connect with your congregation and provide a Census-related message.
  • Video Messaging: Share a Census-related video message with your congregation via email or through social media channels.
  • Social Media: Encourage parishioners to follow @CountOnVirginia on FacebookTwitter, and Instagram for Census-related updates. Leverage your own social media and that of your congregants to spread the word about the 2020 Census.
  • Digital Platforms: Work with local media to share key messages about the upcoming Census. You may consider writing an op-ed or being interviewed by a local reporter.
  • Text Messaging: Encourage parishioners to text PLEDGE or CENSO to (804) 203-0393 for Census updates and reminders.

Monday, March 30 | Social Media Monday
Virginians can “Get Social on Media Monday” by following Virginia’s Census engagement efforts on FacebookTwitter, and Instagram. Virginians are also invited to participate in a Twitter chat about what’s at stake in the 2020 Census. Questions can be tweeted to @CountOnVirginia. Promote the Census using the hashtags #Census2020, #VACompleteCount, and #CountOnVirginia. Additionally, individuals are encouraged to change their Facebook profile picture frames to promote the Census.

Tuesday, March 31 | Text It Tuesday: Pledge to be Counted
The Northam administration has partnered with CommunityConnect Labs to use mobile messaging to connect with hard-to-reach populations. Virginians are encouraged to “Pledge to be Counted” by texting the word “PLEDGE” or “CENSO” (Español) to the number for their respective locality. Participants will receive a digital pledge card that can be shared on social media. Standard text messaging data rates may apply.

Valley: (540) 235-5155
Northern: (703) 684-0007 or (571) 200-0828
Coastal: (757) 210-3232
Southside: (434) 201-4884
Southwest: (276) 218-8138
Central: (804) 203-0393

Wednesday, April 1 | Spread the Word Wednesday
Since 1930, Census Day has been observed on April 1. By this date, all households will have received an invitation to participate in the 2020 Census. Organizations are encouraged to send electronic correspondence to subscribers promoting the 2020 Census and sharing instructions for how individuals can complete the Census online, by phone, or by mail.

Thursday, April 2 | Townhall Thursday
Organizations are encouraged to host virtual townhalls via Facebook Live, Google Hangouts, and other platforms to promote the 2020 Census.

“It’s important that we come together as a community to determine our decade and be counted in the 2020 Census,” Secretary of the Commonwealth Kelly Thomasson. “Taking 10 minutes to complete our Census questionnaires online will help our communities for the next 10 years.”

How to Complete the 2020 Census Online

  • To respond online, go to 2020census.gov. The online form is available in English and 12 other languages. Additionally, video guides showing people how to complete the online questionnaire are available in English and 59 other languages.
  • A sample 2020 Census questionnaire is available here.

About the Virginia Complete Count Commission
On December 18, 2018, Governor Northam signed Executive Order Twenty-Seven establishing the Virginia Complete Count Commission. The purpose of the Commission is to improve participation and representation of all Virginians in the 2020 Census. The Commission facilitates the sharing of ideas and community resources regarding the 2020 Census and serves as a conduit between the Commonwealth and the United States Census Bureau.

The Virginia Complete Count Commission serves as a trusted voice and resource to educate, empower, and engage all communities for the purpose of ensuring that everyone who lives in the Commonwealth of Virginia is counted in the 2020 Census.

For more information on the 2020 Census and Virginia Complete Count Commission, visit census.virginia.gov or follow @CountOnVirginia on FacebookTwitter, and Instagram.

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Kaine & Warner urge administration to approve Virginia National Guard funding request amid COVID-19 outbreak

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 ~ Title 32 approval would provide federal funding for Virginia’s National Guard emergency response missions amid the health crisis ~

WASHINGTON – On March 27, 2020,  U.S. Sens. Mark R. Warner and Tim Kaine (both D-VA), along with U.S. Reps. Bobby Scott (D-VA), Rob Wittman (R-VA), Gerry Connolly (D-VA), Don Beyer (D-VA), A. Donald McEachin (D-VA), Ben Cline (R-VA), Elaine Luria (D-VA), Denver Riggleman (R-VA) Abigail Spanberger (D-VA), and Jennifer Wexton (D-VA) sent a letter to President Donald Trump urging him to swiftly approve federal funding for the Virginia National Guard to help combat the COVID-19 outbreak.

“We write to urge you to quickly approve the request made by Governor Ralph Northam for additional authorities and funding under Title 32 U.S. Code 502(f)(2)(A) to assist the Commonwealth of Virginia to combat the Novel Coronavirus (COVID-19) pandemic. Governor Northam requests this authority and funding for the Virginia National Guard as they work to respond to incidents related to the preservation of life and property in connection with COVID-19 emergency response efforts,” wrote the members of Congress in their letter to President Donald Trump.

Several states across the country have begun to mobilize their National Guards to assist in their response to the coronavirus outbreak. Under Title 32, Virginia’s Governor would have the authority to deploy units to communities across the Commonwealth to help distribute food, support local test facilities, and assist first responders and health providers. Additionally, this request would allow the federal government to cover the cost of these critical missions.

On March 24, the Governor of Virginia determined the need to increase the Virginia National Guard force to full-time status in an effort to help with the coronavirus emergency response across the Commonwealth.

“We urge your prompt approval of this request so Governor Northam may fully task the Virginia National Guard as he finds necessary to support the Commonwealth’s COVID-19 response efforts in support of this national emergency declaration,” they concluded.

Earlier this week, the Senate approved a $2 trillion bipartisan coronavirus economic relief package that includes $1.4 billion for the deployment of the National Guard. This funding level will sustain up to 20,000 members of the National Guard under the direction of the governors of each state for the next six months in order to support state and local response efforts to the health crisis. The House of Representatives will vote on the economic package later today.

A copy of the letter is available here.

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Governor Northam directs postponement of elective surgeries

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~ Order will preserve medical beds and personal protective equipment for COVID-19 response ~

On March 25, 2020, Governor Ralph Northam and State Health Commissioner M. Norman Oliver, MD, MA directed all hospitals to stop performing elective surgeries or procedures to help conserve supplies of personal protective equipment (PPE).

The public health emergency order does not apply to any procedure if the delay would cause harm to a patient. The order also does not apply to outpatient visits in hospital-based clinics, family planning services, or emergency needs.

Earlier this week, Governor Northam recommended that hospitals postpone any elective surgeries, and many have already done so.

“Hospitals and medical facilities in Virginia and around the country are in desperate need of additional masks, gowns, gloves, and other personal protective equipment,” said Governor Northam. “While we work to increase our supply, it makes sense to decrease the demand for that equipment where we can. Postponing elective surgeries allows us to divert more PPE to the medical staff who are dealing with the COVID-19 outbreak so we can better protect the men and men on the front lines of this public health emergency, fighting to keep us all safe.”

Licensed inpatient and outpatient surgical hospitals, free-standing endoscopy centers, physicians’ offices, and dental, orthodontic, and endodontic offices may perform any procedure or surgery that if delayed or canceled would result in the patient’s condition worsening. Outpatient surgical hospitals are encouraged to work with local inpatient hospitals to assist with surge capacity needs. The full text of Order of Public Health Emergency Two is available here.

Virginia received its first shipment of PPE from the national stockpile this week and the state has made its second request. The Governor continues to call for a nationally-led response for acquiring and distributing PPE so that states are not competing against each other, the federal government, and even other countries for the equipment, causing higher prices in the private sector.

Last week, Governor Northam issued Executive Order Fifty-Two that lifts Virginia’s certificate of public need restrictions, allowing hospitals and nursing homes to increase their bed capacity as needed to respond to the COVID-19 pandemic.

Governor Northam has ordered many non-essential businesses to close for 30 days and told Virginians to stay home except for necessary trips out, so as to increase social distancing and slow the spread of the virus.

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Governor Northam COVID-19 update briefing – March 25, 2020

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Each day Governor Northam joins the Virginia Emergency Support Team to share the latest updates on the COVID-19 response. Here is the latest update:

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Children will explore popular books and book series through S.T.E.M. activities, games, food, and more! Tuesday, March 17 –  Children will explore popular books and book series through S.T.E.M. activities, games, food, and more! This[...]
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10:15 Toddler story time | 11:00 Preschool story time Wednesday, March 18 and Thursday, March 19: Our stories, songs, and craft this week will be about friends! Come to story time and see your friends,[...]
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